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Silicone Nephrostomy Catheter
EUDAMEDClass IIb (EU MDR)
Ref 1854-0210Ref 1853-0208Ref 4853-0214Ref 1853-0214Ref 4853-0216Ref 1853-0218Ref 1851-0210
Identity
- Trade Name
- Silicone Nephrostomy Catheter EUDAMED
- Device Name
- Silicone Nephrostomy Catheter EUDAMED
- Model / Reference
- 1854-0210 EUDAMED1853-0208 EUDAMED4853-0214 EUDAMED1853-0214 EUDAMED4853-0216 EUDAMED1853-0218 EUDAMED1851-0210 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 14710961933141 EUDAMED04710961933007 EUDAMED14710961936883 EUDAMED04710961933038 EUDAMED14710961936890 EUDAMED04710961936886 EUDAMED14710961933035 EUDAMED14710961933059 EUDAMED14710961932717 EUDAMED
- Basic UDI-DI
- B-14710961933141 EUDAMEDB-04710961933007 EUDAMEDB-14710961936883 EUDAMEDB-04710961933038 EUDAMEDB-14710961936890 EUDAMEDB-04710961936886 EUDAMEDB-14710961933035 EUDAMEDB-14710961933059 EUDAMEDB-14710961932717 EUDAMED
- EMDN Code
- U040203 NEPHROSTOMY CATHETERS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMEDBelgium EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Silicone Nephrostomy Catheter by Fortune Medical Instrument Corp. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-14710961933141 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Fortune Medical Instrument Corp.
- EUDAMED SRN
- TW-MF-000009221
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (9)
- EUDAMED 6d1576c3-69a1-41f3-a785-410bb439564d 61 fields · synced Aug 4, 2026
- EUDAMED 0f22fa40-97b6-4403-956d-f7bef3ffbb11 61 fields · synced May 16, 2026
- EUDAMED ca1aee0f-6802-402a-86d3-153a2bf2096d 61 fields · synced May 17, 2026
- EUDAMED 5f690391-b8cd-4038-9a1e-60835b7a3d3d 61 fields · synced May 17, 2026
- EUDAMED 7eca8d4c-54e5-43a6-a1aa-7a797d73b15a 61 fields · synced May 17, 2026
- EUDAMED 00929fc5-9a84-4da6-843d-1726789396dd 61 fields · synced May 17, 2026
- EUDAMED 204a1067-9fb8-4f84-b209-45243f413c02 61 fields · synced May 18, 2026
- EUDAMED 59423534-8c37-4ce7-9ef9-294b283ece0f 61 fields · synced May 19, 2026
- EUDAMED 71886c6a-40f1-4016-b676-34cf30897bb4 61 fields · synced May 19, 2026